Background: Knowledge of changes over time in baseline characteristics and tumor necrosis factor inhibitor (TNFi) response in bio-naïve axial spondyloarthritis (axSpA) patients treated in routine care is limited.
Objectives: To investigate secular trends in baseline characteristics and retention, remission and response rates in axSpA patients initiating a first TNFi.
Methods: Prospectively collected data on bio-naïve axSpA patients starting TNFi in routine care from 15 European countries were pooled. According to year of TNFi initiation, three groups were defined a priori based on bDMARD availability: Group A (1999–2008), Group B (2009–2014) and Group C (2015–2018). Retention rates (Kaplan-Meier), crude and LUNDEX adjusted 1 remission (Ankylosing Spondylitis Disease Activity Score (ASDAS) <1.3, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) <20) and response (ASDAS Major and Clinically Important Improvement (MI/CII), BASDAI 50) rates were assessed at 6, 12 and 24 months. No statistical comparisons were made.
Results: In total, 27189 axSpA patients were included (5945, 11255 and 9989 in groups A, B and C).
At baseline, patients in group A were older, had longer disease duration and a larger proportion of male and HLA-B27 positive patients compared to B and C, whereas disease activity was similar across groups.
Retention rates at 6, 12 and 24 months were highest in group A (88%/81%/71%) but differed little between B (84%/74%/64%) and C (85%/76%/67%).
In all groups, median ASDAS and BASDAI had decreased markedly at 6 months (
Conclusion: Nowadays, axSpA patients initiating TNFi are younger with shorter disease duration and more frequently female and HLA-B27 negative than previously, while baseline disease activity is unchanged. Drug retention rates have decreased, whereas crude remission and response rates have increased. This may indicate expanded indication but also a stable disease activity threshold for TNFi initiation over time, an increased focus on targeting disease remission and more available treatment options.
REFERENCES:
[1]Arthritis Rheum 2006; 54: 600-6.
Secular trends in baseline characteristics, treatment retention, remission and response rates in European axSpA patients initiating a 1 st TNFi
Baseline characteristics |
Group A
|
Group B
|
Group C
|
||||||
Age, years, median (IQR) | 57 (49–66) | 51 (42–60) | 46 (37–56) | ||||||
Male, % | 66 | 60 | 57 | ||||||
HLA-B27, % | 87 | 77 | 72 | ||||||
Years since diagnosis, median (IQR) | 5 (1–12) | 2 (0–8) | 2 (0–7) | ||||||
Smokers, % | 23 | 24 | 25 | ||||||
ASDAS, median (IQR) | 3.5 (2.8–4.1) | 3.4 (2.8–4.1) | 3.5 (2.8–4.1) | ||||||
BASDAI, median, (IQR) | 57 (42–71) | 59 (43–72) | 57 (41–71) | ||||||
TNFi drug, % (Adalimumab /
| 22 / 35 / 43 / 0 / 0 | 37 / 21 / 20 / 4 / 18 | 27 / 28 / 24 / 8 / 13 | ||||||
Follow up | 6 months | 12 months | 24 months | ||||||
Gr A | Gr B | Gr C | Gr A | Gr B | Gr C | Gr A | Gr B | Gr C | |
Retention rates, %, (95% CI) | 88 (88–89) | 84 (83–85) | 85 (84–86) | 81 (80–82) | 74 (74–75) | 76 (75–76) | 71 (70–72) | 64 (63–65) | 67 (66–68) |
ASDAS , median, (IQR) | 1.8 (1.2–2.8) | 1.9 (1.2–2.8) | 1.8 (1.2–2.6) | 1.9 (1.3–2.6) | 1.7 (1.2–2.5) | 1.6 (1.1–2.4) | 1.9 (1.4–2.6) | 1.7 (1.1–2.4) | 1.5 (1.1–2.2) |
ASDAS inactive disease , %, c/L | 28 / 25 | 28 / 24 | 30 / 26 | 24 / 19 | 32 / 24 | 34 / 26 | 23 / 16 | 34 / 20 | 39 / 23 |
ASDAS CII , %, c/L | 57 / 51 | 59 / 50 | 63 / 54 | 61 / 50 | 63 / 47 | 67 / 51 | 59 / 41 | 68 / 40 | 74 / 45 |
ASDAS MI , %, c/L | 31 / 27 | 32 / 27 | 37 / 32 | 32 / 26 | 37 / 27 | 41 / 31 | 30 / 20 | 42 / 25 | 46 / 28 |
BASDAI , median, (IQR) | 23 (10–40) | 26 (11–48) | 24 (10–44) | 21 (10–38) | 23 (10–42) | 20 (8–39) | 22 (9–40) | 20 (8–39) | 16 (6–35) |
BASDAI remission , %, c/L | 44 / 40 | 40 / 34 | 43 / 36 | 45 / 36 | 45 / 34 | 50 / 38 | 44 / 30 | 48 / 29 | 56 / 34 |
BASDAI 50 response , %, c/L | 53 / 47 | 50 / 42 | 53 / 45 | 57 / 46 | 56 / 42 | 58 / 44 | 57 / 39 | 60 / 35 | 63 / 38 |
Gr, Group; c/L, crude/LUNDEX adjusted.
Acknowledgements: Novartis Pharma AG and IQVIA for supporting the EuroSpA Research Collaboration Network.
Disclosure of Interests: Lykke Midtbøll Ørnbjerg Grant/research support from: Novartis, Sara Nysom Christiansen Speakers bureau: BMS and GE, Grant/research support from: Novartis, Simon Horskjær Rasmussen: None declared, Anne Gitte Loft Speakers bureau: AbbVie, Janssen, Lilly, MSD, Novartis, Pfizer, UCB, Consultant of: AbbVie, Janssen, Lilly, MSD, Novartis, Pfizer, UCB, Grant/research support from: Novartis, Ulf Lindström: None declared, Jakub Zavada: None declared, Florenzo Iannone: None declared, Fatos Onen: None declared, Michael J. Nissen Speakers bureau: Novartis, Eli Lilly, Celgene, and Pfizer, Consultant of: Novartis, Eli Lilly, Celgene, and Pfizer, Brigitte Michelsen Consultant of: Novartis, Grant/research support from: Novartis, Maria Jose Santos Speakers bureau: AbbVie, Novartis, Pfizer, Gary Macfarlane Grant/research support from: GlaxoSmithKline, Dan Nordström Consultant of: Abbvie, BMS, MSD, Novartis, Pfizer, Roche, UCB, Manuel Pombo-Suarez: None declared, Catalin Codreanu Speakers bureau: AbbVie, Amgen, Egis, Novartis, Pfizer, UCB, Grant/research support from: AbbVie, Amgen, Egis, Novartis, Pfizer, UCB, Matija Tomsic Speakers bureau: Abbvie, Amgen, Biogen, Medis, MSD, Novartis, Pfizer, Consultant of: Abbvie, Amgen, Biogen, Medis, MSD, Novartis, Pfizer, Irene van der Horst-Bruinsma Speakers bureau: Abbvie, BMS, MSD, Novartis, Pfizer, Lilly, UCB, Björn Gudbjornsson Speakers bureau: Amgen and Novartis, Johan Askling: None declared, Bente Glintborg Grant/research support from: Pfizer, Biogen, AbbVie, Karel Pavelka Speakers bureau: AbbVie, Roche, MSD, UCB, Pfizer, Novartis, Egis, Gilead, Eli Lilly, Consultant of: AbbVie, Roche, MSD, UCB, Pfizer, Novartis, Egis, Gilead, Eli Lilly, Elisa Gremese: None declared, Nurullah Akkoc: None declared, Adrian Ciurea Speakers bureau: Abbvie, Eli-Lilly, MSD, Novartis, Pfizer, Eirik kristianslund: None declared, Anabela Barcelos: None declared, Gareth T. Jones Grant/research support from: Pfizer, AbbVie, UCB, Celgene, Amgen, GSK, Anna-Mari Hokkanen Grant/research support from: MSD, Carlos Sánchez-Piedra: None declared, Ruxandra Ionescu Speakers bureau: Abbvie, Amgen, Boehringer-Ingelheim Eli-Lilly,Novartis, Pfizer, Sandoz, UCB, Ziga Rotar Speakers bureau: Abbvie, Amgen, Biogen, Medis, MSD, Novartis, Pfizer, Consultant of: Abbvie, Amgen, Biogen, Medis, MSD, Novartis, Pfizer, Marleen G.H. van de Sande: None declared, Arni Jon Geirsson: None declared, Mikkel Østergaard Speakers bureau: AbbVie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Centocor, GSK, Hospira, Janssen, Merck, Mundipharma, Novartis, Novo, Orion, Pfizer, Regeneron, Schering-Plough, Roche, Takeda, UCB and Wyeth, Consultant of: AbbVie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Centocor, GSK, Hospira, Janssen, Merck, Mundipharma, Novartis, Novo, Orion, Pfizer, Regeneron, Schering-Plough, Roche, Takeda, UCB and Wyeth, Merete L. Hetland Speakers bureau: Abbvie, Biogen, BMS, Celltrion, Eli Lilly, Janssen Biologics B.V, Lundbeck Fonden, MSD, Pfizer, Roche, Samsung Biopies, Sandoz, Novartis.